Table 1.
Reported study characteristics of included cohorts
| Author | Year | Country and involved centres | Type of study | Treatment (higher dose) | Comparator | Participants in treatment arm | Participants in comparator arm | Type of disease | Duration of disease (months) | Duration of FU (months) | Baseline %FVC | Baseline %DLCO |
| Mankikian et al 12* | 2023 | France Multicentre |
Randomised controlled trial | MMF (2000 mg/die) | N/A* | 59 | N/A* | ILD with NSIP pattern | 34.8 | 12 | 70.2 | 38.6 |
| Nadashkeviech et al 14 | 2006 | Ukraine and Canada Multicentre |
Randomised unblinded trial | AZA (2.5 mg/kg/die) | CYC (2.0 mg/kg/die) | 30 | 30 | SSc | 6.6 | 18 | 91.7 | 84.8 |
| Naidu et al 15 | 2020 | India Monocentric |
Randomised controlled trial | MMF (2000 mg/die) | Placebo | 20 | 21 | SSc | 72 | 6 | 75.6 | 43 |
| Roig et al 21 | 2010 | Spain Monocentric |
Not randomised unblinded trial | AZA (2 mg/kg/die | CYC (750 mg/m2 pulsed intravenous) | 25 | 21 | IPF | NA | 24 | 76 | 68 |
| Volkmann et al 19 | 2017 | USA Multicentric |
Post hoc analysis from two RCTs | MMF (3000 mg/die) | Placebo | 69 | 79 | SSc | 25.2 | 24 | 66.5 | 54 |
| Zhang et al 20 | 2015 | China Monocentric |
Randomised unblinded trial | MMF (1500 mg/die) | Placebo | 30 | 30 | CTD-ILD | NA | 12 | 72.3 | 58 |
| Derk et al 9 | 2009 | USA Monocentric |
Prospective open label | MMF (1500 mg ×2/die) | N/A | 15 | N/A | SSc | 11 | 12 | 99.2 | 71.2 |
| Henes et al 10 | 2012 | Germany Monocentric |
Prospective open label | Enteric-coated mycophenolate sodium (540 mg/die) | N/A | 11 | N/A | SSc | 26 | 12 | 78.0 | 75.1 |
| Liossis et al 11 | 2006 | Greece Monocentric |
Prospective open label | MMF (2000 mg/die) | N/A | 6 | N/A | SSc | NA | 8 | 65.6 | 64.2 |
| Mendoza et al 13 | 2012 | USA Monocentric |
Prospective open label | MMF (average dose 2.02 g/die) | N/A | 25 | N/A | SSc | <24 | N/A | N/A | 69 |
| Paone et al 16 | 2007 | Italy Monocentric |
Prospective open label | AZA (2 mg/kg/die) | N/A | 13 | N/A | SSc | 16 | 12 | 89.5 | 73.6 |
| Simeón-Aznar et al 17 | 2011 | Spain Monocentric |
Prospective open label | Mycophenolate sodium (720 mg ×2/die) | N/A | 14 | N/A | SSc | 78 | 12 | 64 | 40 |
| Vaiarello et al 18 | 2020 | Italy Monocentric |
Prospective open label | MMF (1500 mg ×2/die) | N/A | 10 | N/A | SSc | 60 | 24 | 73 | 68 |
*Participants of the interventional arm (MMF+rituximab) of this study have not been included in the systematic review.
AZA, azathioprine; CTD, connective tissue disease; %DLCO, per cent predicted diffusion lung capacity of carbon monoxide; FU, follow-up; %FVC, per cent predicted forced vital capacity; ILD, interstitial lung disease; IPF, Idiopathic Pulmonary Fibrosis; MMF, mycophenolate mofetil; N/A, not available; RCT, randomised controlled trial.